MHRA grants Almac IMP licence for radiolabelling service

Published: 22-Jul-2009 Featured companies: Almac Group
Ingredients Regulatory

Almac has extended its radiolabelling services to include drug product and has received an IMP licence from the UK Medicines and Healthcare products Regulatory Agency (MHRA).


Almac has extended its radiolabelling services to include drug product and has received an IMP licence from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Customers can now access a full range of radiolabelling services for large (peptides and proteins) and small molecules.

Almac's QA manager Alan Chambers said: "The IMP licence award is a major milestone for our radiolabelling offering and now enables Almac to manufacture radiolabelled drug product for direct use in clinical studies. This achievement places Almac at the forefront of the global GMP radiolabelling industry."

The company offers a fully integrated set of services, RAPIDDTM (Accelerated Process Integrated Drug Development) including API, formulation, analytical, pre-clinical safety assessment and regulatory documentation to complete lead candidate to entry into Phase I clinical trials in under 12 months.

The Almac Group employs more than 2,400 people and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.

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